Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

Not Recruiting

Trial ID: NCT02224898


The research objective of this pilot study is to test the feasibility of a mobile electronic mindfulness therapy service for patients with definite or suspected chronic pancreatitis. A secondary aim will be to determine the effect of the intervention on a symptom severity/global assessment of improvement for patients with chronic pancreatitis. The investigators hypothesize that a one-month period of daily mindfulness therapy delivered via a phone messaging service will reduce symptoms.

Official Title

Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

Stanford Investigator(s)

Walter Park
Walter Park

Associate Professor of Medicine (Gastroenterology and Hepatology)


Inclusion Criteria:

   - For the study group: Patients with diagnosis of chronic pancreatitis with at least two
   of the following features: clinical course consistent with chronic pancreatitis,
   calcification in the pancreas on US/CT/EUS, ERCP showing ductal abnormalities
   (Cambridge Classification), exocrine insufficiency, histology showing irregular
   fibrosis, acinar cell loss, islet cell loss, and inflammatory cell infiltrates, or
   other features suggestive of chronic pancreatitis (such as pancreatic pseudocyst). The
   study group will also include patients with suspected chronic pancreatitis based on
   history of documented pancreatitis with lingering symptoms or signs of early chronic
   pancreatitis on imaging.

   - For the control group: no history of chronic GI symptoms lasting greater than 8 weeks,
   no gastrointestinal disease or condition diagnosis, and not be currently experiencing
   gastrointestinal symptoms.

   - Age 18 to 80

   - Willing to give informed consent

   - Able to complete entire study

   - Ability to speak and read English

   - Regular menstrual cycles or menopause for at least 6 months

   - Owns a mobile phone with texting capabilities

   - Unlimited minutes and text messaging dataplan for mobile phone

   - Physically and mentally capable of using a mobile phone

   - Phone access

Exclusion Criteria:

   - Red flags of concern: anemia, blood in stools, unexplained weight loss, unexplained

   - Pregnant or nursing woman, or planning on becoming pregnant within next year

   - Travel plans outside of the county over the study duration or a month prior

   - Change in medications one month prior or during study

   - Change in chronic pancreatitis management strategies one month prior or during study
   such as dietary changes, exercise, counseling and behavioral therapies.

   - Current co-morbid condition that might account for GI symptoms

   - Current infectious diseases: HIV, Hepatitis A, B or C, other

   - Psychiatric Conditions: moderate to severe depression (ECT, unable to work, disrupts
   ADL's), moderate to severe anxiety (unable to work, disrupts ADL's), bipolar disorder,
   schizophrenia, or history of psychosis, suicidal ideation or attempt, substance abuse
   (alcohol and/or drugs in past year), dissociative disorder, dementia related disorder

   - Immunologic Diseases: systemic lupus, moderate to severe arthritis, scleroderma, other

   - Gastrointestinal Disorders: inflammatory bowel diseases (ulcerative colitis, Crohn's),
   celiac disease,personal history of colon cancer or polyps, other unless condition
   associated with chronic pancreatitis.

   - Cardiovascular disorder, clinically significant in past 12 months

   - Pain disorder, clinically significant (back pain, fibromyalgia)

   - Recent surgery, during 6 months prior to study enrollment or during study period
   (except minor surgeries such as wisdom teeth extraction, cataract surgery, corrective
   lens surgery, and/or minor skin surgeries)

   - Major stressor(s) in life 3 months prior to study or anticipated over the next month


behavioral: Mobile Mindfulness Therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305